The Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
NCT Number: NCT02370992
Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.
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Inclusion criteria
Prostate (cancer) related:
Exclusion criteria
Unable to give informed consent.
I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice
Time frame: Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
This change will be measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
Time frame: Measured at 1 mth.
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Time frame: Measured at 3 mth.
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Time frame: Measured at 6 mth.
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
Time frame: Measured at 12 mth.
Incidence of seed loss at 1 month and 6 months after implant and Biochemical disease free survival (Phoenix-definition.)
The Leeds Teaching Hospitals NHS Trust
Other
Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection
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